CMC Regulatory Writing
Our experienced team of regulatory writers can provide the following CMC regulatory services for Module 2 and Module 3 sections of regulatory submissions:
- Author or review of regulatory documents (IND, IMPD, NDA, MAA)
- Provide CMC regulatory strategy consultation for drug substance and drug product
- Interpretation and application of regulatory guidance
- On-going support for regulatory submissions (annual reports, post-approval amendments, etc.)
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